Maviret

Table of contents

Overview

Maviret is an antiviral medicine used to treat adults and adolescents aged 12 years and older with chronic (long-term) hepatitis C, an infectious disease that affects the liver, which is caused by the hepatitis C virus.

Maviret can only be obtained with a prescription, and treatment should be started and monitored by a doctor experienced in the management of patients with hepatitis C virus infection.

Maviret is available as tablets that contain 100 mg glecaprevir and 40 mg pibrentasvir. The recommended dose is three tablets once a day, with food, for 8, 12 or 16 weeks. The duration of treatment depends on whether patients have liver cirrhosis (scarring of the liver) or whether they have received previous treatments with pegylated interferon and ribavirin, with or without sofosbuvir, or sofosbuvir and ribavirin.

For more information about using Maviret, see the package leaflet or contact your doctor or pharmacist.

The active substances in Maviret, glecaprevir and pibrentasvir, block two proteins essential for the hepatitis C virus to multiply. Glecaprevir blocks the action of a protein called NS3/4A protease, while pibrentasvir blocks a protein called NS5A. By blocking these proteins, Maviret stops the hepatitis C virus from multiplying and infecting new cells.

There are 6 varieties (genotypes) of the hepatitis C virus and Maviret has been shown to be effective at clearing all genotypes from the blood.

In 8 main studies involving over 2,300 adults with hepatitis C, 99% of non-cirrhotic patients with genotype 1, the most common genotype, tested negative for the virus after 8 weeks of Maviret treatment and 97% cirrhotic patients were negative after 12 weeks. A negative test result means that the virus was not found. Results were similar for genotypes 2 and 4-6. The medicine’s effectiveness in clearing genotype 3 was slightly lower than for other genotypes (95%).

In a study in 47 children aged between 12 and 18 years with genotypes 1 to 4 and without cirrhosis, all patients tested negative for the virus after 12 weeks of treatment. In addition, results showed that the way the medicine was absorbed, modified and removed from the body was similar to that in adults. Based on data available in adults, it is expected that Maviret is also effective in children with genotypes 5 and 6.

The most common side effects with Maviret (which may affect more than 1 in 10 people) are headache and tiredness.

Maviret must not be used in patients with severely reduced liver function. It must also not be used together with certain medicines such as:

atorvastatin, simvastatin (medicines for lowering cholesterol levels in the blood);

For the full list of restrictions and side effects with Maviret, see the package leaflet.

Maviret has been shown to be highly effective in clearing the hepatitis C virus from the blood, particularly in patients who have not been treated previously or who do not have cirrhosis. The fact that Maviret can be given without ribavirin and without dose adjustments in patients with severe kidney problems is a further advantage in comparison with similar medicines. With regard to its safety, Maviret’s pattern of side effects raises no particular concern.

The European Medicines Agency therefore decided that Maviret’s benefits are greater than its risks and it can be authorised for use in the EU.

The company that markets Maviret will carry out a study in patients who previously have had liver cancer to evaluate the risk of liver cancer returning after treatment with direct-acting antivirals such as Maviret. This study is being carried out in light of data suggesting that patients treated with medicines

belonging to the same class as Maviret and who have had liver cancer could be at risk of their cancer returning early.